Home / Recalls / InvaGen Pharmaceuticals, Inc. / D-0698-2018

D-0698-2018 Class III Terminated

Recalled by InvaGen Pharmaceuticals, Inc. — Central Islip, NY

FDA drug recall D-0698-2018 was initiated by InvaGen Pharmaceuticals, Inc. on Mar 5, 2018 and is designated Class III. Reason for recall: Failed impurities/degradation specifications: Failure to water content and impurity The recall status is terminated (terminated Jan 20, 2021). Affected quantity: 3222 vials.

Recall Details

Product Type: Drugs
Report Date: Apr 18, 2018
Initiation Date: Mar 5, 2018
Termination Date: Jan 20, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3222 vials

Product Description

Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37

Reason for Recall

Failed impurities/degradation specifications: Failure to water content and impurity

Distribution Pattern

U.S.A. nationwide

Code Information

Lot #: GE70493, GE70502, GE70512, Exp 8/2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0698-2018
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

Other recalls by InvaGen Pharmaceuticals, Inc.

D-0220-2024 Class I — Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx… (Nov 17, 2023)
D-1272-2020 Class III — Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for… (May 14, 2020)
D-1454-2019 Class III — Testosterone Topical Solution 30mg of testosterone per pump actuation * each… (Jun 12, 2019)
D-1123-2019 Class II — Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For… (Mar 22, 2019)
D-1124-2019 Class II — Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial… (Mar 22, 2019)
D-1125-2019 Class II — Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For… (Mar 22, 2019)
D-0012-2019 Class III — Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured… (Oct 3, 2018)
D-1212-2018 Class III — Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle… (Sep 6, 2018)
D-0619-2018 Class III — buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC… (Mar 15, 2018)
D-0618-2018 Class III — buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx… (Mar 15, 2018)